The invention relates to a vial docking station for simultaneously sliding the spouts of a plurality of liquid medicament vials into an engaged position with matching receptacles of a like plurality of liquid reconstitution diluent bags.
In hospital pharmacies, a common activity is to prepare several intravenous delivery bags with saline solutions for example to be mixed with various liquid medicaments to the specification of doctors. Often, the liquid medicines are provided in vials or glass bottles with a rubber sheet diaphragm across the spout of the bottle sealed with a metal rim and removable seal. The liquid medicines can be accessed by hypodermic needle for example, piercing through the rubber diaphragm and withdrawing liquid medicine into a hypodermic needle. Also commonly in hospitals, the vials are provided in measured doses by the drug manufacturer and the hospital pharmacy prepares intravenous solutions by engaging the spouts of the vials with matching receptacles on the sealed sterile diluent bags. The receptacles include sliding or telescoping means to engage a piercing needle on the receptacle and release the medicine from the vials into the saline solution in the diluent bag by permitting air to pass one way into the vial and thereby releasing the liquid through the needle.
Manually engaging the vials with receptacles of diluent bags involves many risks including physical injury or biological contamination from sharp needles, contamination of adjacent atmosphere with powerful or toxic medicines, and exposure of pharmacy workers to long term low concentrations of drugs. In order to address these risks, the prior art includes various mechanical devices to ensure safe engagement of vials with the receptacles and includes mechanical devices that can be positioned under exhaust hooks to avoid contamination.
U.S. Pat. No. 5,037,390 to Raines et al. shows a method of preparing diluent solution bags from a number of different vials of medicines of different sizes. The fluid medicament from the vials is conducted through a perforated needle in a one way valve into a manifold, which conducts the mixture of medicines to a diluent bag for delivery to the patient.
U.S. Pat. No. 6,070,761 to Bloom et al. shows a complex automatic system for mixing medicines for multiple vials that are delivered through needles into a plastic cassette with various channels and vials are mixing and delivering the medicament to an automatic delivery system.
Simple manual mechanisms for engaging a diluent bag with piercing needle and vials minimizing the risk of injury and exposure are shown in several patents such as U.S. Pat. No. 5,826,713 to Sunago et al., U.S. Pat. No. 5,478,337 to Okamoto et al. and U.S. Pat. No. 5,364,386 to Fukuoka et al. Apart from the examples mentioned above, it is considered well known to those in the relevant art that various devices are available for connecting vials containing medicaments with flexible diluent bags containing saline solutions.
A significant disadvantage of the prior art devices is the high cost and mechanical complexities. Due to these disadvantages, many hospital pharmacies rely on the physical labour of pharmacists to connect vials with receptacles individually. This method leads to fatigue and mistakes, personal injury and exposure to biological hazards as well as concentrated medicines which impose unacceptable risks to workers in hospital pharmacies as a result.
An unrecognised, but major cause of illness and some times death is human error in preparing medicines, which are delivered in the wrong concentration or to the wrong patient.
It is an object of the present invention to provide a simple low cost reliable tool for engaging vials of various sizes to diluent bags thus avoiding human contact and physical exertion as much as possible.
It is a further object of the invention to provide a mechanical system wherein vials of different sizes can be prepared in a ready position and double-checked before mixing for example with bar code readers in an optical checking system.
It is a further object of the invention to provide optional manually operated vial docking station and pneumatic or hydraulically operated version without significant modification to the mechanism.
Further advantages of the invention will be apparent from the following detailed description and accompanying drawings.
The invention provides a vial docking station for simultaneously sliding the spouts of a plurality of liquid medicament vials into an engaged position with matching receptacles of a like plurality of liquid reconstitution diluent bags. The vial docking station has a support frame that can be mounted to a wall or within an exhaust hood to reduce the risk of exposure.
The frame has a stationary bag mounting block with a series of spaced apart receptacle mounts. The mounts are C-shaped for suspending the diluent bags from their flexible inlet tube and receptacles below the mounting block. For different sizes or designs of receptacles, the mounts can include replaceable inserts or ferrules of different designs.
A header block is slidably mounted to the frame and has an equal number of plungers that are used to hold vials in an upturned position and to force the vial spout into sliding engagement with the receptacle. Each plunger is spring loaded or biased to firmly hold and guide the base of an associated vial in a ready position. In this position the vial is upturned to flow out under gravity when the seal diaphragm is pierced with the needle of the receptacle. The vial spout is aligned with the receptacle ready to be forced into sliding engagement with the plungers. Each plunger is manually individually operable between the ready position and a retracted position wherein the vial base is manually lifted against the force of gravity and spring load to be disengaged from the plunger.
Plunger clamps are disposed on the header block, for releasably clamping each plunger to move with the header block. A manually operated or mechanically operated actuation mechanism is mounted to the frame and engages the plunger clamps and the moveable header block for moving the header block progressively from the ready position forward to the engaged position, and rearward to a withdrawn position and for actuating the plunger clamps during movement between the ready position and the withdrawn position.
The plungers have a head with a conical self-centering vial base mating socket and a rod slidably mounted to the header block. The plunger head is spring loaded toward the bag mounting block to hold the vials ready in an upturned position above the bag receptacles.
The plunger clamp has a lock lever pivotally mounted to the header block for rotation about an axis transverse to the plunger rod. The rod extends through an aperture through the lock lever and the lock lever can move between a free sliding position and a clamped position wherein lock lever is disposed relative to the plunger rod with peripheral edges of the aperture gripping an outer surface of the rod. The offset aperture therefore binds or grips the cylindrical rod.
Further advantages of the invention will be apparent from the following detailed description and accompanying drawings.